89th Legislature

SB 984

Overall Vote Recommendation
Yes
Principle Criteria
Free Enterprise
Property Rights
Personal Responsibility
Limited Government
Individual Liberty
Digest
SB 984 establishes a legal framework in Texas for patients with life-threatening or severely debilitating illnesses to access individualized investigational treatments. These are experimental drugs, biological products, or medical devices uniquely designed for a single patient based on their genetic profile—examples include gene therapies, antisense oligonucleotides, and neoantigen vaccines. These treatments are not yet fully approved by the U.S. Food and Drug Administration (FDA) but may offer hope when standard therapies have failed.

Under the bill, healthcare facilities are eligible to administer these treatments if they operate under a federal assurance program for the protection of human subjects, as outlined in 42 U.S.C. § 289(a) and 45 C.F.R. Part 46. To qualify, patients must have exhausted FDA-approved treatment options, provide written informed consent, and receive a physician's recommendation based on a genomic analysis. The treating physician must also attest to the patient’s eligibility and recommend the treatment based on the patient's unique medical and genetic profile.

SB 984 does not mandate insurers to cover these treatments and relies on private arrangements between patients, providers, and treatment developers. The law is designed to respect patient autonomy, expand access to medical innovation, and reduce regulatory barriers without creating new state agencies or enforcement mechanisms. The bill adds Chapter 491 to Subtitle C, Title 6 of the Texas Health and Safety Code.
Author
Paul Bettencourt
Sponsor
Ken King
Fiscal Notes

According to the Legislative Budget Board (LBB), SB 984 is not expected to have a significant fiscal impact on the state budget. The bill does not establish any new state programs or regulatory bodies, and it leverages existing federal human subject protection frameworks, meaning that implementation would not require substantial new state expenditures. Any administrative costs incurred by state agencies—such as the Texas Medical Board or the Health and Human Services Commission—are anticipated to be minimal and manageable within existing agency resources.

For local governments, the bill similarly poses no significant fiscal impact. It does not create any mandates for local entities, nor does it establish any funding mechanisms that would require local match or compliance spending. As such, cities, counties, and local health departments are not expected to incur costs under this legislation.

State agencies consulted in the fiscal note, including the Employees Retirement System, Texas Department of Insurance, Texas Medical Board, Texas A&M University System, and University of Texas System, did not report any anticipated fiscal challenges in implementing or adapting to the provisions of the bill. Overall, SB 984 is a low-cost policy change that expands access to investigational treatments without imposing financial burdens on public entities.

Vote Recommendation Notes

SB 984  advances the Right to Try framework in Texas by specifically targeting patients with rare or ultra-rare diseases who may benefit from individualized investigational treatments, such as personalized gene therapies. These patients often have no access to clinical trials due to the small number of affected individuals and the lack of commercial viability. SB 984 provides a critical legal and procedural pathway for these individuals to pursue treatments developed uniquely for them, under the care of their physicians and within federal safety parameters.

The bill is crafted with built-in safeguards: it requires that treatment be administered through federally approved facilities and institutional review boards, and it mandates informed consent and physician attestation. Importantly, the legislation protects healthcare providers from professional or Medicaid-related penalties and bars state interference with patients’ access to compliant treatments. These provisions underscore the bill’s commitment to preserving individual liberty and promoting medical freedom without growing the size or cost of government.

From a fiscal perspective, the Legislative Budget Board anticipates no significant cost to the state or local governments, as implementation relies on existing resources and does not mandate coverage or services. Moreover, the bill refrains from creating new bureaucracies or enforcement bodies. Given its narrow but meaningful scope, its alignment with core liberty principles—especially individual autonomy, personal responsibility, and limited government—and its low fiscal impact, Texas Policy Research recommends that lawmakers vote YES on SB 984.

  • Individual Liberty: The bill significantly enhances individual liberty by affirming the right of patients with life-threatening or severely debilitating illnesses to make autonomous choices about their healthcare. It gives these patients legal access to individualized investigational treatments—such as gene therapies tailored to their unique genetic makeup—when no FDA-approved or viable clinical options exist. This expansion of the original "Right to Try" concept empowers individuals to act in defense of their own lives without undue governmental restriction, reinforcing the core idea that individuals should have control over their own medical decisions, especially under dire circumstances.
  • Personal Responsibility: The bill supports personal responsibility by requiring patients to provide informed consent and by involving the treating physician in confirming eligibility and treatment necessity. Patients must exhaust all FDA-approved options before seeking investigational alternatives. This structure ensures that decisions are informed, voluntary, and medically justified. It reinforces the principle that individuals and their doctors, not bureaucrats, are best equipped to weigh medical risks and benefits.
  • Free Enterprise: While not directly deregulating the marketplace, the bill indirectly supports innovation in personalized medicine by removing legal barriers to the use of patient-specific therapies. It allows manufacturers and facilities operating under federal protections to provide these treatments and sets no mandate for compensation, giving them flexibility in determining whether and how to offer such services. This can encourage biotech firms to invest in developing individualized therapeutics, thereby fostering medical innovation within a freer market environment.
  • Private Property Rights: The bill does not address land use or tangible personal property rights. However, by protecting the voluntary exchange of services between patients and providers, it upholds the broader economic liberty associated with property and contract rights, albeit indirectly.
  • Limited Government: The bill explicitly limits the role of the state in personal medical decisions. It prohibits state agents from blocking access to lawful investigational treatments and prevents state licensing boards and Medicaid administrators from punishing providers who recommend such treatments. The bill refrains from creating new agencies or regulatory burdens, thereby preserving a minimal, non-intrusive government role consistent with Texas's constitutional tradition of decentralized authority.
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